BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZEPHYR DR

    MDR report key: 3875071 · Received June 16, 2014

    Report

    Report Number
    2017865-2014-13832
    Event Type
    Death
    Date Received
    June 16, 2014
    Date of Event
    January 27, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWP
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS DECEASED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENTS FOLLOWING PHYSICIAN WAS NOT AWARE THE PATIENT HAD DECEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353103 ZEPHYR DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC., CRMD 5820 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death